Top Stories for the Week of Feb. 26th 2007

Top News

Study Broker with Past Debts Resurfaces Under New Name

A study broker working under multiple names and who owed at least one site tens of thousands of dollars in back payments has resurfaced with a new company called Drug Research America with a street address in Las Vegas, Nevada. C.S. Thibodeau solicited business from a site network on Feb. 13, 2007, and a contract research organization on Nov. 2, 2006.

Averion Expands European Presence; Cuts Costs

Boston, Mass.-based contract research organization (CRO) Averion International has opened four new offices in Europe, significantly expanding its coverage in the region. The new locations in the UK, Austria and Poland will each focus on specific geographic regions within Europe. In addition, the firm has established its European headquarters in Neu Isenburg, Germany.
   
Other breaking news...  

• Clinsys changes its name...
• LifeTree eClinical in contract with Stereotaxis   

Company Profile: An interview with Douglas Gregory, Ph.D., president and CEO, Cardiovascular Clinical Studies (CCS) and Cardiovascular Core Laboratories (CCL)

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

>Internal benchmarking tracks activities and is extremely important to measure progress toward goals. External benchmarking is generally a case of chasing the other guy’s tail. If the external data can be validated then those data will also have value.

> Good ethics and high scientific and medical standards can and should be used as a means to beat the competition.  Regulatory agencies may raise the bar for others developing similar products, if you have raised it yourself.

> Using minimally acceptable criteria for continuing with a product’s development facilitates the best business decisions and helps to avoids games being played on prematurely terminating or prolonging a dying or even a dead project.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of  Bert Spilker & Associates (BS&A).

Lancet Says Industry is 'Medicalizing' Everyday Problems

Posted by: Stephen DeSantis

A group of healthcare experts have published a series of six essays in the  British medical journal Lancet discussing direct-to-consumer (DTC) advertising and what they see as the 'Medicalizing' of modern society. HealthDay Reporter Ed Edelson explores the issue in a well-balanced piece published yesterday at HealthDay News.

You can read the story here or by continuing reading below:

Anapharm Under New Leadership

Posted by: Stephen DeSantis

Princeton, N.J.-based PharmaNet Development Group is showing more signs of positive change as it attempts to move forward after troubled times. It announced this week that it appointed Johane Boucher-Champagne president and chief executive of its Anapharm unit, a phase I and bioequivalencey business based in Quebec City, Canada.

She has been acting chief executive since December and began working at Anapharm as its chief operating officer in 1998. Boucher-Champagne will replace Marc LeBel who founded Anapharm in 1996. Anapharm was acquired by SFBC International, now PharmaNet, in 2002.

In August 2006—after emerging from a year of legal and financial blows and bad publicity concerning recruitment of illegal immigrants in phase I trials—SFBC changed its name to PharmaNet Development Group, a company it acquired in 2004 for $245 million in cash.

The company closed its Miami facility, effectively ending its phase I and bioequivalencey business in the U.S. The Anapharm group kept its name and became the company's only remaining early stage unit. It operates solely in Canada.

Anapharm had its own round of controversy last year after at least 19 subjects were exposed to, and nine patients tested positive for tuberculosis (TB) while enrolled in a non-TB related trial.

A 37-year-old man with an active case of the disease was included in the trial, and there were reports that he was kept in the on-site study with subjects despite visible symptoms of illness. The issue prompted Health Canada to require new patients be screened for contagious diseases and monitored for specific symptoms.

Game Plan For The Next Pharma Leaders

Posted by: Steve Zisson

Where should Big Pharma’s next leaders come from?

If you believe that the biotech model is the future of drug development, then executives coming up through the ranks of Big Pharma might be excluded from the top spots. Many experienced pharma execs would be out of the running for CEO. As Big Pharma searches for the way forward, they may seek outsiders such as fumbling Ford did with Alan Mulally from Boeing.

But drug research and development is a difficult business for most non-scientists, and for Big Pharma to get innovative, looking to biotech execs may be the best place to search for their next leaders.

The field is limited, however. There just aren’t that many successful biotech companies. And would a top biotech CEO from a Genentech or a Genzyme even want to leave their successful companies?

And who would want to take on the huge task of transforming pharma?

Top Stories for the Week of Feb. 19th 2007

Top News

Medidata and Fast Track Partner for eClinical Integration

New York, N.Y.-based eClinical vendor Medidata Solutions signed a multi-year agreement with Fast Track Systems, a software and clinical service provider based in Pennylvania, that allows the companies to offer clients the integration of Fast Track's TrialSpace Designer (TSD) study design software with Medidata's electronic data capture (EDC) tool Rave.

Children's Hospital Boston Research Team Creates New Drug Forecasting Tool

Initially spurred on by the lack of clinical research conducted on children and seeking to make the process of drug development less costly, two pediatric researchers from Children's Hospital Boston, Asher Schachter, M.D. and Marco Ramoni, Ph.D, have developed a tool based on Bayesian statistics.

Other breaking news...      

• ICON reports big gains...
• Accium strikes deal with Affinium...

Company Profile:An interview with JeanMarie Markham, president, Clinlogix

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

 

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> Ask yourself whose responsibility it is to create a strategy that will recruit patients. If you said “the investigator” you are wrong. It is the sponsor’s responsibility to create a strategy that will be successful, and if it is not, to readjust it and to apply necessary resources to insure it succeeds.

> Open-label clinical trials often mislead a company as the data obtained have a much greater likelihood of being positive than if the same trial was done in a double blind manner.  This may lead to a company wasting years of effort and millions of dollars until hey recognize that the drug really did not demonstrate efficacy in a true double blind study.

> Insure that any compassionate plea protocols are in your company’s interests. This requires a balance of ethical responsibilities with practical issues. The practical issues include resources required, value of the data obtained and whether your program is being slowed and allowing competitors to catch up or move ahead of you.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of  Bert Spilker & Associates (BS&A).

CenterWatch Monthly: February 2007 Issue

Big Pharma Collaborates for Inter-Company Auditing Agreement

As part of its strategic risk management of service providers, F. Hoffman-La Roche has spearheaded an initiative that standardizes and streamlines the auditing process among six collaborating sponsor companies. These six big pharma have joined forces to share the generic results of some of the cyclical, routine audits each conduct, thereby obviating the need for the other five to conduct the same audit. All have already benefited from significant cost and time savings.

Pediatric Clinical Trial Growth Stunted

The laws mandating pediatric clinical trials are set to expire later this year. In the past 10 years, the FDA has requested 760 pediatric studies. But growth has slowed as companies quickly handled the backlog. Some pediatric trial organizations have ceased doing business.

Europe Anticipates Surge in Pediatric Drug R&D

Drug companies, contract research organizations (CROs), regulators, and patient advocates are braced for the impact of the European Commission's new pediatric regulation, which came into force last month. More than 50% of medicines given to children in Europe have never been put through pediatric clinical trials, and have not been specifically approved for pediatric use.

Eye On: Diarrhea

Diarrhea, defined as loose, watery and frequent bowel movements, is considered chronic when it persists for more than four weeks. In adults, diarrhea is usually mild and resolves quickly without complications, but in infants and children younger than age 3, diarrhea can rapidly lead to dehydration.

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

ICON Reports Banner Year; Central Lab Business Swings Back

Posted by: Stephen DeSantis

In line with the banner year shared by much of clinical trials industry, the Dublin, Ireland-based contract research organization (CRO) ICON reported big gains in 2006. The company generated $129 million in net revenue, a 46% increase compared with $88.1 million during the same period in 2005. The company had full year revenues of $455.6 million in 2006 compared with $342.8 million in 2005, representing an increase of 33%. ICON’s operating income rose 69% to $51.9 million in 2006 compared with $30.8 million in 2005.

“2006 has been an outstanding year for ICON,” said company chairman John Climax. “Our central lab achieved a significant turnaround from losses of $6.6 million last year to profits of $1.3 million. Our clinical segment achieved very strong growth in 2006 and improved its margins from 11.9% in 2005, to 12.4%. With a record backlog of $872 million, we look forward with confidence to 2007.”

ICON was awarded $171 million in net new business during the fourth quarter, a 22% increase. Full year net business awards totalled $665 million, a 42% increase on last year.

The company has changed its financial year reporting to end on Dec. 30th versus reporting twelve months ending on Nov. 30. Therefore its 2006 year end results including the month of December 2005 revenues as well.

The company held its fourth quarter conference on February 13, 2007. This call and linked slide presentation can be accessed live on ICON's investor relations website. Click here to listen to the archived conference call.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Natural Remedies May Interfere With Clinical Trials

Posted by: Stephen DeSantis

Patients taking alternative medicine may be affecting phase I clinical trial data reports Steven Reinberg at HealthDay News. Researches polled 212 patients enrolled in phase I cancer trials about their use of vitamins, herbal preparations, minerals and other dietary supplements.

According to the report in the February 10th issue of the Journal of Clinical Oncology:

"Prior CAM [Complementary and Alternative Medicine] use among phase I cancer trial patients studied was common and associated with age, stated acknowledgment of prognosis, and quality of life. Patients enrolling onto early-phase trials should be questioned about CAM use."

Read the full article here or continue reading below...

Top Stories for the Week of Feb. 12th 2007

Top News

Academic Community Offers Guidance for Financial Disclosure

A multi-institutional research team led by Johns Hopkins' Berman Institute of Bioethics has devised a model for disclosing any financial interests of clinical investigators to potential trial participants. The research team consisted of experts at Johns Hopkins University, Duke University and Wake Forest University. The new model was reported in the January 2007 issue of IRB Ethics and Human Research. The model resulted from a five-year project funded by a $3 million dollar grant from the National Heart, Lung, and Blood Institute (NHLBI).

Cystic Fibrosis Foundation Invests in 45 New Sites

The Cystic Fibrosis Foundation (CFF) will expand its investigative site network with a $3 million award distributed among 45 new research centers in 20 states nationwide. The funds were awarded by Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), a non-profit subsidiary of CFF and fully funded by the foundation.

Other breaking news...  

• Medidata signs deal with Orion...
• PPD revenue up...   

Company Profile: An interview with Jerry Merritt, chief executive officer, Cetero Research

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> Avoid procedure bloat, which occurs when a clinical trial protocol is prepared by taking the previous one and adding some additional tests. This is fairly common as a drug passes through the development path.

> As soon as patient enrollment decreases below projections by a fixed number determined in advance of the trial, seek to learn the cause. Determine if this is evident at all or only some sites (i.e., is it site-specific or protocol-specific).  Either adjust the protocol or change the recruitment strategy. Do not simply add sites until you determine that that is a reasonable action and is likely to address the problem.

> Monitors must understand the intensity and latitude they are allowed in their monitoring activities. Sometimes it may only be necessary to monitor the high enrollers, or a random group of sites in large trials.  In mega-trials it is impossible and not regulatoraly required to monitor these trials as extensively as pivotal trials.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of  Bert Spilker & Associates (BS&A).

Uncommon Partners In Search For A Cure

Posted by: Sara Gambrill

The recent partnership between the Juvenile Diabetes Research Foundation (JDRF), a non-profit that funds type 1, or juvenile, diabetes research, and MacroGenics, a biotechnology company, may seem very unusual—even controversial—at first glance. A charity giving millions to a for-profit company? The simple answer is that both want to find a cure for Type 1 diabetes, but the trend is worth a look.

Under the arrangement the non-profit will provide up to $2 million to fund a pivotal, multinational phase II/III clinical trial designed to assess the effectiveness, tolerance and safety of a compound called teplizumab. This compound is an anti-CD3 humanized monoclonal antibody capable of suspending the auto-immune attack that destroys insulin-producing beta cells in people with recent-onset, Type 1 diabetes in children and adults newly diagnosed with the disease, according to MacroGenics.

Should a non-profit disease foundation gamble on an experimental compound that may not receive FDA approval? The answer depends largely on the type of disease studied...

Phase Forward Sees 22% Jump in Revenues

Posted by: Stephen DeSantis

Waltham, Mass.-based eClinical company Phase Forward reported a 22% jump in revenues to $106.6 million in 2006, compared with the previous year’s $87.1 million. In the fourth quarter of 2006, the company posted revenues of $30.2 million, a 28% increase compared with the fourth quarter of 2005.

Income from operations was $4.1 million, representing an increase of 67% from the prior year period and an operating margin of 13.6%. Income from operations was $13.2 million in 2006, representing an increase of 46% from 2005 and a full year operating margin of 12.4%. Net income was $16.2 million, or $0.45 per diluted share, for the full year compared with $12.7 million, or $0.36 per diluted share in 2005. Phase Forward’s share price jumped 7% to $14.49 on Feb. 1.

The company also won a contract with the Dublin-based CRO ICON. The agreement will be under Phase Forward’s CRO Advantage Program. ICON secured four studies in the fourth quarter that will use Phase Forward’s EDC solution, InForm. Phase Forward stated it added 38 new clients in 2006, including CardioFocus, Altana Pharma AG (now part of Nycomed)  Teijin Pharma and Orexigen.

“The fourth quarter was a strong finish to an excellent year for Phase Forward. During 2006, we accomplished key objectives such as winning numerous major purchase decisions, expanding and diversifying our customer base, and enhancing our market leadership position,” said Bob Weiler, chief executive officer for the firm.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Top Stories for the Week of Feb. 5th 2007

Top News

Medifacts Will Sell CRO Unit after Filing for Bankruptcy

Medifacts International plans to sell off its contract research division after filing for Chapter 11 bankruptcy protection in the United States Bankruptcy Court of Delaware.

University of Michigan Creates Emergency Care Trials Network

The University of Michigan (U-M) and a team of more than a dozen academic researchers have created a new clinical trials network called the Neurological Emergencies Treatment Trials Network (NETT).   

Other breaking news...  

• Averion signs agreement with India-based Apothecaries...
• Phase Forward revenues jump...   

Company Profile: An interview with J. Tobin Geatz, president and chairman of the board, Inclinix

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

Bert Spilker's Pharma Principles of The Week

Posted Bert Spilker

> Work hard to avoid protocol amendments as they consume a great deal more resource than one imagines in staff time to prepare, review and implement them. Some vendors have systems to minimize the numbers of amendments a company will need, by subjecting protocols to multiple internal checks of consistency, and comparisons with other protocols that have been conducted.

> The number of patients available to join a trial drops by about 90% the day a trial begins. This is referred to as “Lasagna’s Law” and is mitigated by using only inclusion criteria that are truly required and by reviewing potential enrollees prior to choosing the site investigators.

> Locate world class experts through professional associations, trade associations, local experts who can tell you the world’s top people in his area, FDA reviewing divisions, FDA Advisory Committee members, other companies in the therapeutic area, and/or literature citations of those quoted most often.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of  Bert Spilker & Associates (BS&A).

 

Progress On Clinical Results Transparency

Posted by: Sara Gambrill

Since the International Committee of Medical Journal Editors (ICMJE) announced in September 2004 that it would consider for publication an article about a research project only if it was posted to a central registry before September 13, 2005, pharmaceutical companies have committed significant personnel, time and money to the issue of clinical trials transparency. And their efforts are paying off.

According to an editorial published recently in the New England Journal of Medicine, only 8% of clinical trials listed in the first 11 months of 2006 on clinicaltrials.gov, the National Institutes of Health’s registration web site, had incomplete information, compared to 26% of trials listed before 2006.

Thomson CenterWatch estimates that industry spending on trial registries will continue to rise. In 2005, the top 15 biopharmaceutical companies spent $89 million for various efforts to disclose clinical trial information, and CenterWatch estimates that they will spend $97 million this year...